前瞻性评价特定 Absorb BVS 植入策略在 ST 段抬高型心肌梗死中的应用：BVS STEMI STRATEGY-IT 研究。
A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study.
机构信息
Cardiology Division, ASST Bergamo Est, Bolognini Hospital Seriate, Seriate, Italy.
Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy.
出版信息
JACC Cardiovasc Interv. 2017 Sep 25;10(18):1855-1864. doi: 10.1016/j.jcin.2017.07.023.
OBJECTIVES
The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI).
BACKGROUND
Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention.
METHODS
This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days.
RESULTS
During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported.
CONCLUSIONS
A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781).
目的
本研究旨在评估在 ST 段抬高型心肌梗死（STEMI）患者中，按照预先设定的生物可吸收支架（Absorb BVS）植入策略的可行性和临床结果。
背景
由于在初次经皮冠状动脉介入治疗（pPCI）后 30 天内和中期随访时，报道了不可忽视的血栓形成率，人们对 Absorb 的安全性提出了担忧。
方法
这是一项前瞻性、多中心研究，纳入了 STEMI 患者（年龄<75 岁，症状发作<12 小时），这些患者接受 pPCI 治疗，并按照专用植入方案植入 Absorb BVS。主要终点是 30 天内以器械为导向的复合终点，包括心脏性死亡、靶血管心肌梗死和缺血驱动的靶病变血运重建。
结果
在研究期间，505 例 STEMI 患者（STEMI 总人群的 16.9%）接受 Absorb BVS 治疗。平均年龄为 56.6±9.4 岁，入院时 487 例（96.4%）患者为 Killip Ⅰ级或Ⅱ级。根据研究方案，直接植入 Absorb 是可行的，在 47 例（9.3%）患者中实施，而在 468 例（92.7%）患者中进行了后扩张。94.8%的病例获得了手术成功。在 481 例（95.1%）患者中，出院时给予替格瑞洛或普拉格雷双联抗血小板治疗。在 30 天随访时，以器械为导向的分层复合终点发生率为 0.6%（0.4%心脏性死亡，0.2%靶血管心肌梗死和缺血驱动的靶病变血运重建）。报告了 1 例（0.2%）可能的支架血栓形成。
结论
在接受 pPCI 的 STEMI 患者中，按照预先设定的 Absorb 植入策略是可行的，与 30 天的以器械为导向的复合终点发生率低相关。需要进行中期和长期随访，以最终确认这些早期结果。（在 ST 段抬高型心肌梗死（STEMI）中使用 BVS：STEMI 策略-IT 前瞻性注册研究[STRATEGY-IT]；NCT02601781）。
Zotero 插件